Further study details as provided by Children's Investigational Research Program, LLC:

Primary Outcome Measures:

* Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents. [ Time Frame: 7, 14 and 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of responders versus non-responders with L. reuteri versus placebo at end of the study. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.

Debut of colic symptoms 6+/-1 days before randomization

Gestational age between 37 and 42 weeks

Apgar score higher than 7 at 5 minutes

Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period

Written informed consent from one or both parents

Stated availability throughout the study period

Exclusion Criteria:

Major chronic disease

Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria

Administration of anitbiotics the week before randomization

Administration of probiotics the week before randomization

Participation in other clinical trials

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067027